The effect of high-intensity interval training(HIIT) and quercetin supplementation on oxidative stress, level of concentric pathologic hypertrophy and cardiac function in patients with hypertension and CAD after PCI.
the effect of high-intensity interval training(HIIT) and quercetin supplementation on oxidative stress and level of concentric pathologic hypertrophy in patients with hypertension and CAD after PCI.
Design
A concealed, randomized, blinded, sham controlled clinical trial with a parallel group
Settings and conduct
In this semi experimental randomized, placebo‑controlled and double‑blind study, 36 men with hypertension and CAD after PCI aged 40-60 years, randomly divided into 3 groups of HIIT+quercetin(n=12), HIIT+placebo(n=12) and quercetin(n=12) were followed for 8 weeks of HIIT (30 seconds of activity and 30 seconds of rest) and quercetin consumption (250 mgr of quercetin supplement or placebo pills daily). Echocardiography was used to investigate morphological factors such as PWd and LVEDd. The TAC and MDA were measured by ELISA method. Data were analyzed using paired-sample T-test and ANOVA.
Participants/Inclusion and exclusion criteria
men with hypertension and CAD after PCI
Intervention groups
HIIT+quercetin(n=12), HIIT+placebo(n=12) and quercetin
Main outcome variables
MDA , TAC ,EF, LVEDd, PWd
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160927030023N3
Registration date:2020-02-20, 1398/12/01
Registration timing:retrospective
Last update:2020-02-20, 1398/12/01
Update count:0
Registration date
2020-02-20, 1398/12/01
Registrant information
Name
Khalilullah Moonikh
Name of organization / entity
Rajai Teacher Training University
Country
Iran (Islamic Republic of)
Phone
+98 21 2297 0060
Email address
kh.moonikh@srttu.edu
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
2018-12-22, 1397/10/01
Actual recruitment end date
2019-03-21, 1398/01/01
Trial completion date
2019-09-29, 1398/07/07
Scientific title
The effect of high-intensity interval training(HIIT) and quercetin supplementation on oxidative stress, level of concentric pathologic hypertrophy and cardiac function in patients with hypertension and CAD after PCI.
Public title
The effect of high-intensity interval training(HIIT) and quercetin supplementation on oxidative stress, level of concentric pathologic hypertrophy and cardiac function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least 2 and up to 4 weeks after angioplasty (drug stent only),
Male
40-60 years old
Systolic hypertension (SBP <130 mmHg <130 )
Mild to moderate congenital cardiac hypertrophy
Exclusion criteria:
Patients' non-adherence to exercise protocol
Exercise outside the rehabilitation center
Non-compliance with supplement use (less than 80% or less than 1 day)
Changing health and abnormal change of medication
People who have a history of kidney failure, heart attack or heart valve surgery, have aortic stenosis, dilated cardiomyopathy, and EF below 30%, are in frequent practice of PVC or AF.
Leaving practice sessions over 1 week or more than 3 dispersed sessions
Age
From 40 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
36
Actual sample size reached:
36
Randomization (investigator's opinion)
Randomized
Randomization description
In this research simple randomization method is used.
The participants will be divided into 3 groups of 12 people. For this purpose, from 1 to 3 each number is written 12 numbers on the paper and participants are asked to assign a number to each of them and group them according to their number.
Blinding (investigator's opinion)
Double blinded
Blinding description
Prior to the study, supplement and placebo cans were marked by a person other than the researcher to inform the researcher and subjects of the type of capsules received. Supplement and placebo were administered under the same supervision.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sport Sciences Research Institue of IRAN
Street address
NO 3, 5th alley, Miremad Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2019-03-19, 1397/12/28
Ethics committee reference number
IR.SSRI.REC.1397.373
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
2
Description of health condition studied
CAD
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
MDA
Timepoint
Before and after 8 weeks
Method of measurement
Elisa
2
Description
TAC
Timepoint
Before and after 8 weeks
Method of measurement
Elisa
3
Description
LVEDd
Timepoint
Before and after 8 weeks
Method of measurement
Eco cardiography
4
Description
PWDd
Timepoint
Before and after 8 weeks
Method of measurement
Eco cardiography
5
Description
EF
Timepoint
Before and after 8 weeks
Method of measurement
Eco cardiography
Secondary outcomes
1
Description
Systolic blood pressure
Timepoint
Before and after 8 weeks
Method of measurement
Manometer
2
Description
Diastolic blood pressure
Timepoint
Before and after 8 weeks
Method of measurement
Manometer
Intervention groups
1
Description
Intervention group: 250 mg doses of 1 capsules of quercetin+ HIIT for 8 weeks
Category
Rehabilitation
2
Description
Control group: 2 + placebo control group resistance training for 8 weeks